510(k) · Cleared
ClearedSureWave Elastography (Q7000225)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 12, 2025 as substantially equivalent to K201389 (Resoundant, Inc., 2020) and 1 other predicate after a 218-day review. Its family tree reaches back 14 generations to 1995. 7 of the 135 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 12, 2025
- Review
- 218 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K935595 (1995). 134 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet. 7 of the 135 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 2 generations backK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
- 1 generation backK140666 MR ElastographyPhilips Medical Systems Nederland B.V. · 2014
- This deviceK242006 SureWave Elastography (Q7000225)Quality Electrodynamics, LLC · 2025
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 5 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 4 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 2 generations backK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
- 1 generation backK140666 MR ElastographyPhilips Medical Systems Nederland B.V. · 2014
- This deviceK242006 SureWave Elastography (Q7000225)Quality Electrodynamics, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −2 | K083421 | MR-Touch Option | Ge Medical Systems, LLC | 2009 | — |
| −1 | K140666 | MR Elastography | Philips Medical Systems Nederland B.V. | 2014 | — |
| 0 (this device) | K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 8 | 0 |
| 2001 | 12 | 1 |
| 2002 | 10 | 1 |
| 2003 | 10 | 1 |
| 2004 | 13 | 1 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 1 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 1 |
| 2011 | 3 | 0 |
| 2012 | 1 | 1 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
7 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201389 | Resoundant Acoustic Driver SystemSummary page 5…maging d. Regulation Number 892.1000 e. Product Code(s) LNH 3. Legally Marketed Predicate Devices a. K201389, Resoundant Acoustic Driver System, Product Code LNH b. K140666, MR Elastography, Product Code LNH Quality Electro… | 2020 |
| * | K140666 | MR ElastographySummary page 5…e. Product Code(s) LNH 3. Legally Marketed Predicate Devices a. K201389, Resoundant Acoustic Driver System, Product Code LNH b. K140666, MR Elastography, Product Code LNH Quality Electrodynamics, LLC. Traditional 510(k) SureWave Elastography… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 43 of the 134 ancestors have a recall of any class; 7 have a Class I recall.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242006: SureWave Elastography (Q7000225).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242006
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026